NCT07349706NARecruiting

IMST for Dementia Risk Reduction

Florida State University

Start Date

11/17/2025

Completion Date

12/1/2026

Summary

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Detailed Description

This is a 2-arm randomized pilot trial (N=30), including adults aged 60-80 years of age with cardiovascular risks for dementia. Participants will complete assessments prior to beginning the study, each week during the intervention, and at the conclusion of the 8-week intervention. Participants in the experimental group will complete daily high-resistance IMST training (e.g., 75% maximal inspiratory pressure), and participants in the sham condition will complete IMST training at 15% maximal inspiratory pressure. Investigators hypothesize the following: Hypothesis 1: Participants in the high-resistance IMST group will show greater reductions in systolic blood pressure and other vascular health indicators compared to those in the sham IMST group after 8 weeks. Hypothesis 2: Participants in the high-resistance IMST group will demonstrate greater improvements in executive cognitive function than those in the sham group. Hypothesis 3: IMST will lead to secondary improvements in mood (reduced depression and anxiety symptoms), better sleep quality (as measured by self-report and actigraphy), and improved physical function (e.g., grip strength, gait speed). Hypothesis 4: The IMST protocol will be feasible and acceptable, with at least 80% adherence to prescribed training sessions over the 8-week period.

Eligibility Criteria

Age Range: 60 years to 80 years

Inclusion Criteria: * Ages 60-80 * Converted telephone MoCA total score≥18 * Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension \[SBP \>130 mmHg or on medication\], sedentary lifestyle \[\<150 min/week\], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score \[\>5\] * Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST) * Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks) * Optional inclusion of inspiratory muscle weakness (MIP \<80 cmH₂O for men, \<70 cmH₂O for women) will also be assessed. Exclusion Criteria: * tMoCA \<18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI) * Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \> 20) * Unstable cardiovascular or pulmonary disease * Recent respiratory therapy or major medication changes * Self-reported severe untreated or unstable obstructive sleep apnea (OSA) * Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training * Lung and eardrum injuries * Non-English speaking * Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.

Interventions

DEVICE

Inspiratory Muscle Strength Training High-Resistance

DEVICE

Inspiratory Muscle Strength Training Low-Resistance

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Conditions

Systolic Blood PressureBlood PressureDepression - Major Depressive DisorderAnxietySleep QualityPhysical FunctionCognitive Function

Locations

Florida State University

Tallahassee, Florida 32301

United States